FDA granted accelerated approval to Farydak (panobinostat) for the treatment of multiple myeloma. The FDA had previously granted Farydak priority review and an orphan product designation.
The FDA issued a safety alert regarding the design of endoscopic retrograde cholangiopancreatography duodenoscopes, and how it may impede effective cleaning of the reusable device.
Bristol-Myers Squibb Company and Rigel Pharmaceuticals Inc. entered into a collaboration for the discovery, development and commercialization of cancer immunotherapies based on Rigel's portfolio of small molecule TGF beta receptor kinase inhibitors.
FDA granted Rintega (rindopepimut) a Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma.
FDA granted accelerated approval to Ibrance (palbociclib) to treat metastatic breast cancer.
FDA approved Lenvima (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Lenvima was approved following a priority review.
The U.K. National Health Service established an access program for the Oncotype DX test, developed by Genomic Health Inc., for breast cancer patients, effective April 1.
FDA granted an Orphan Drug Designation to Reolysin for the treatment of pancreatic cancer.
FDA granted an Orphan Drug Designation to antinuclear antibody conjugated liposomal doxorubicin, developed by NanoSmart Pharmaceuticals Inc., for the treatment of Ewing's sarcoma, a rare cancer that develops in or around children's bones.
FDA granted an Orphan Drug Designation to Saposin C, the active ingredient in drug BXQ-350, for the potential treatment of glioblastoma multiforme.
